FDA.reportPublic FDA data

Mag-AL Plus XS

Manufacturer
Cardinal Health 107, LLC
Effective date
2026-09-09
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
daily-update
Hydrated at
2026-09-22 03:02:16

Label at a glance#

ProductMag-Al Plus XS
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE, UNSPECIFIED
Label structure9 sections

Indications and uses

• acid indigestion • heartburn • sour stomach • upset stomach due to these symptoms • pressure and bloating commonly referred to as gas

Dosage and administration

• shake well before using • do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks adults and children 12 years and older take 2 to 4 teaspoonfuls two times a day or as directed by a physician children under 12 years consult a physician

Storage and handling

• each 5 mL contains: magnesium 167 mg, sodium 2.24 mg • store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. • protect from freezing • White colored, cherry flavored liquid supplied in the following oral dosage form: Overbagged with 5 x 30 mL unit dose cups in each bag, NDC 55154-9422-5 WARNING: This Unit Dose package is not child resistant and is Intended for Instit...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 5 mL = 1 teaspoonful)Purpose

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Antacid

Magnesium hydroxide 400 mg

Antacid

Simethicone 40 mg

Antigas

Uses for the relief of:

INDICATIONS & USAGE SECTION

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach due to these symptoms
  • pressure and bloating commonly referred to as gas

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not take more than 8 teaspoonfuls in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney disease
  • a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms last more than 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

adults and children 12 years and older

take 2 to 4 teaspoonfuls two times a day or as directed by a physician

children under 12 years

consult a physician

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: magnesium 167 mg, sodium 2.24 mg
  • store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
  • protect from freezing
  • White colored, cherry flavored liquid supplied in the following oral dosage form:

Overbagged with 5 x 30 mL unit dose cups in each bag, NDC 55154-9422-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

*Maalox is a registered trademark of Novartis Consumer Health, Inc.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, sodium saccharin, and sorbitol solution.

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L36154990525

F1762300721

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-9422-5

MAG-AL PLUS XS

5 CUPS

2400mg/2400mg/240mg in 30mL bag label
2400mg/2400mg/240mg in 30mL bag label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130055154942256GTIN-13: 0055154942256
EAN-13: 0055154942256
GTIN-12: 055154942256
UPC-A: 055154942256
GTIN storage (14 digits): 00055154942256		b950b648-4292-4b99-ad30-52f554434f27-00.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1762-30ML - Milliliter0121-176215a221d5-f2b9-4738-a87a-18544a2c7c7112014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN04
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O4
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004S4
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN04
DIMETHICONEACTIVE MOIETY92RU3N3Y1O4
HYDROXIDE IONACTIVE MOIETY9159UV381P4
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV84
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY4
SORBITOLINACTIVE INGREDIENT506T60A25R4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55154-942255154-9422-5
0121-1762

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
BUTYLPARABEN3QPI1U3FV8IACT
HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35IACT
PEPPERMINT OILAV092KU4JHIACT
CYCLOMETHICONE 4CZ227117JEIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122025-06-06full-release2026-06-01 01:02:29

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e5449db-1064-409f-a417-98dada2638b78ea0287c-2264-4b5d-8f37-2cf3733936c72025-06-06WarningsExact identifier
spl set id: 8ea0287c-2264-4b5d-8f37-2cf3733936c7
Mag-AL Plus XSALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEPAI Holdings, LLC dba PAI Pharmadb0c47ab-5296-4195-9fa6-2e338b6650942024-11-12WarningsExact identifier
ndc (product): 0121-1762

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.